Deviation Management Specialist Assistant

Job Title

Qualifications:

B.S./M.S. degree in appropriate engineering/scientific field

Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/biotech industry

Previous experience in writing investigations for atypical events in a manufacturing environment

Familiar with Lean Six Sigma Methodologies and proven analytical/problem solving capabilities

Demonstrated ability to work both independently and as a part of a cross-functional team

Excellent written and verbal communication skills

Responsibilities:

Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigations

This individual will be responsible for providing scientific support for manufacturing areas within Merck's Manufacturing Division (MMD)

This Individual will also develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release and is required to utilize sound scientific and engineering principles to investigate process deviations

Troubleshooting and root cause analysis of manufacturing atypical events, development of corrective/preventative actions is required

Analysis of complex problems through critical analytical thinking

Off-shift work may be required.